Adults 18 to 75, any sex, with Palmoplantar Pustulosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index (PPPASI)Primary· Baseline to Week 16
The Palmoplantar Pustulosis Area and Severity Index (PPPASI) is used to assess the severity of palmoplantar pustulosis lesions and their response to therapy. The glabrous skin of both palms and both soles are assessed for erythema, pustules, and desquamation (scaling), each on a scale from 0 (none) to 4 (very severe). The area affected of each palm and sole is scored from 0 (0%) to 6 (90-100%). Scores for the 3 characteristics of PPP are summed and adjusted for the area affected, and the scores for each palm and sole are added to calculate the total score. The PPPASI total score ranges from 0
Group
Value
95% CI
Placebo
-6.0
± 1.48
Imsidolimab
-6.1
± 1.46
Number of Participants With Treatment-emergent Adverse Events (TEAEs)Primary· From first dose of any study drug to Week 24
Clinical safety was evaluated by reporting incidence of adverse events up to week 24. TEAEs are defined as new events that occured during or after first dose of study drug or any event that worsens after first dose of study drug.
A serious AE (SAE) is defined as any untoward medical occurrence that resulted in death, was life-threatening, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or an important medical event that may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above.
Severity was asse
Any treatment-emergent adverse event (TEAE)
Group
Value
95% CI
Placebo
20
Imsidolimab
21
TEAE related to study drug
Group
Value
95% CI
Placebo
3
Imsidolimab
6
Severe TEAE
Group
Value
95% CI
Placebo
1
Imsidolimab
0
Serious TEAE
Group
Value
95% CI
Placebo
1
Imsidolimab
0
TEAE of special interest
Group
Value
95% CI
Placebo
1
Imsidolimab
0
TEAE leading to discontinuation of study treatment
Group
Value
95% CI
Placebo
2
Imsidolimab
1
TEAE leading to study discontinuation
Group
Value
95% CI
Placebo
1
Imsidolimab
1
TEAE leading to death
Group
Value
95% CI
Placebo
0
Imsidolimab
0
Percentage of Participants Who Achieved 50% Reduction (Improvement) From Baseline in Palmoplantar Pustulosis Psoriasis Area Severity Index Score (PPPASI 50)Secondary· Baseline to Week 16
The Palmoplantar Pustulosis Area and Severity Index (PPPASI) is used to assess the severity of palmoplantar pustulosis lesions and their response to therapy. The glabrous skin of both palms and both soles are assessed for erythema, pustules, and desquamation (scaling), each on a scale from 0 (none) to 4 (very severe). The area affected of each palm and sole is scored from 0 (0%) to 6 (90-100%). Scores for the 3 characteristics of PPP are summed and adjusted for the area affected, and the scores for each palm and sole are added to calculate the total score. The PPPASI total score ranges from 0
Group
Value
95% CI
Placebo
50.0
29.12 – 70.88
Imsidolimab
45.8
25.55 – 67.18
Percentage of Participants Who Achieved a Clear or Almost Clear Palmoplantar Pustulosis Investigator's Global Assessment (PPPIGA) Score at Week 16Secondary· Week 16
The Investigator rated the severity of participants' disease on the following 5-point scale:
* 0: Clear - No signs of palmoplantar pustulosis; no scaling or crusts or pustules remain;
* 1: Almost clear - Slight scaling and/or erythema and/or slight crusts; very few (yellow) and/or old (brown) pustules;
* 2: Mild - Scaling and/or erythema and/or crusts; visible new (yellow) and/or old (brown) pustules of limited number and extent;
* 3: Moderate - Prominent scaling and/or erythema and/or crusting; prominent new (yellow) and/or old (brown) pustules covering most of the area involved;
* 4: Severe
Group
Value
95% CI
Placebo
12.5
2.66 – 32.36
Imsidolimab
20.8
7.13 – 42.15
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of any study drug to Week 24.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple doses of imsidolimab (ANB019) in adults with palmoplantar pustulosis (PPP)
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04856930 — A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis S
· Phase 2
· completed
NCT04856917 — A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
· Phase 2
· completed
NCT04697069 — A Study to Evaluate of the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Acneiform Rash
· Phase 2
· terminated
NCT04697056 — A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis
· Phase 2
· terminated
NCT03619902 — A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis
· Phase 2
· completed
Other recruiting trials for Palmoplantar Pustulosis
Currently open trials in the same condition.
NCT07219420 — A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis
· Phase 3
· recruiting
NCT07013201 — A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to
· Phase 2
· recruiting
Other Vanda Pharmaceuticals trials
Trials by the same sponsor.
NCT07446439 — A Study to Evaluate Tradipitant on Treating Nausea and Vomiting Induced by GLP-1R Agonist Use
· Phase 3
· recruiting
NCT06804603 — A Study to Measure the Effects of Using Tradipitant on Nausea and Vomiting After GLP-1R Agonist Use
· Phase 2
· completed
NCT06701396 — Evaluating the Effects of Tasimelteon Vs. Placebo in Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant
· Phase 3
· recruiting
NCT06494397 — Pharmacokinetic Study of VHX-896 and Iloperidone Tablets Under Steady-State Conditions
· Phase 1
· completed
NCT05903924 — Motion Serifos: A Study to Investigate the Efficacy of Tradipitant in Participants Affected by Motion Sickness
· Phase 3
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vanda Pharmaceuticals
Last refreshed: 15 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03633396.